Aerosol dispensing inhaler training device

ABSTRACT

An aerosol dispensing inhaler training device for determining whether a user is properly operating an aerosol dispensing device. The training device includes an aerosol dispensing device having a container with a valve stem extending longitudinally therefrom and movable between a closed position and an open position. The container dispenses a portion of the contents within the container when the valve stem is moved to the open position. The aerosol dispensing device includes a housing adapted to support the container reciprocally moveable within the housing along a longitudinal axis from a first position, the housing comprising a well adapted to receive the valve stem and an exhaust port comprising one end in fluid communication with the well and a second end in fluid communication with the ambient atmosphere, wherein the portion of the contents within the container is dispensed from the first end of the exhaust port to the second end of the exhaust port when the housing moves to an actuation position where the valve stem is actuated so that a portion of the contents within the container is dispensed through the second end of the exhaust port when the valve stem is moved to the open position. An actuation sensor generates a signal that indicates when the housing is moved to the actuation position and the valve stem is actuated. A shake sensor determines whether the contents within the container have been properly agitated for consumption by a user.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates generally to an aerosol dispensinginhaler training device, and in particular, to an aerosol dispensinginhaler training device that can monitor several parameters, such as theflow rate, shaking of the container and the activation of the containercomprising a solution or suspension which upon actuation transforms intoan aerosol.

[0003] 2. Description of Related Art

[0004] Aerosol administered medication for bronchial therapy in suchconditions as asthma, chronic bronchitis and emphysema is generally thepreferred dosage technique for reasons of efficacy, reduced side effectsand economy. Such particulate drugs are commonly prescribed usingmetered dose inhaler (MDI) type devices. It is well recognized thatimproper inhalation technique in the use of MDI devices is a seriousbarrier to effective therapy.

[0005] Some patients may have difficulty in the use of conventional MDIdevices especially in terms of controlling inhalation, and properactivation timing of the MDI delivery system. For example, patients mayinhale too fast, or in an erratic manner. Another common problem is thatpatients may delay activation of the MDI device until after inspirationhas started, and therefore, the crucial initial portion of the inspiredbreath does not contain medication. After activation, patients mayfrequently begin their MDI inspiration breaths at improper levels oflung volume, for example, their lungs may already be relatively full ofair and therefore a proper large volume of inspired air is impossible.

[0006] Once the proper MDI inspiration breath has been achieved, it isimportant for the patient to sustain a brief period of breath holding sothat the medicated mist is properly deposited in the airways of thepatient.

[0007] The desired time interval of breath holding is generally thoughtto be about five to ten seconds. However, this desirable time may befunctionally limited, as dictated by individual patient needs and breathholding capabilities.

[0008] While it is generally felt the timing of MDI activation should besimultaneous with the beginning of inspiration, there is some scientificopinion that questions whether said activation should be a fraction of asecond before or after the beginning of inspiration. However, it isunderstood that these events are substantially concurrent.

[0009] It should be apparent from the above, that while the act of usingan MDI device may appear simple, it can be in fact a complex act, andthe proper performance of this technique is crucial to the optimaldelivery of drugs to the bronchial airways. Without proper MDIinhalation technique, the patient may in fact derive little or nobenefit from this form of drug therapy.

[0010] In this vein, there have been attempts in the past to measure themagnitude of the flow rate and the timing of the dispensing of theaerosol along with improving the training of individuals to use a properMDI inhalation technique. In the case of measuring the flow rate, manytechniques have been used in the past ranging from pressure differentialtechniques (i.e., pneumotachs that measure pressure drop across a timemeshed screen with a linear resistance, a bundle of capillary tubes witha linear resistance, a fixed orifice or a flexible orifice) tomechanical techniques (i.e., spinning turbines, paddle wheels, hingedflaps with potentiometers) to ultrasonic techniques (i.e., time offlight pulses). One disadvantage to the above flow rate techniques,except the ultrasonics technique, is that the liquid particles presentin a patient's exhaled gas can contaminate the flow rate devices to theextent that they produce inaccurate readings. The ultrasonics techniquesuffers the drawback that it requires relatively expensive piezoelectricelements and complex signal analysis that limits widespread application.

[0011] In the case of teaching proper usage of a metered dose inhaler,past devices and systems have omitted teaching the proper technique forshaking the aerosol container prior to inhalation.

SUMMARY OF THE INVENTION

[0012] One aspect of the present invention regards an aerosol dispensinginhaler training device for determining whether a user is properlyoperating an aerosol dispensing device. The training device includes anaerosol dispensing device having a container with a valve stem extendinglongitudinally therefrom and movable between a closed position and anopen position. The container dispenses a portion of the contents withinthe container when the valve stem is moved to the open position. Theaerosol dispensing device includes a housing adapted to support thecontainer reciprocally moveable within the housing along a longitudinalaxis from a first position, the housing comprising a well adapted toreceive the valve stem and an exhaust port comprising one end in fluidcommunication with the well and a second end in fluid communication withthe ambient atmosphere, wherein said portion of the contents within thecontainer is dispensed from the first end of the exhaust port to thesecond end of the exhaust port when the housing moves to an actuationposition where the valve stem is actuated so that a portion of thecontents within the container is dispensed through the second end of theexhaust port when the valve stem is moved to the open position. Anactuation sensor generates a signal that indicates when the container ismoved to the actuation position and the valve stem is actuated. A shakesensor determines whether the contents within the container have beenproperly shaken for consumption by a user.

[0013] A second aspect of the present invention regards a method oftraining an individual on how to properly use an aerosol dispensingdevice. The method includes providing an aerosol dispensing inhalertraining device with a container, agitating the contents of thecontainer, determining whether the contents of the container have beenproperly agitated during the agitating step for consumption by anindividual; and repeating the previous steps if it is determined thatduring the agitating step that the contents of the container have notbeen properly agitated for consumption by an individual.

[0014] The present invention provides significant advantages over otheraerosol dispensing inhaler training devices. In particular, severalaspects of the present invention's use of a flow rate measurement devicewith reduced risk of being contaminated by a patient's exhaled gas whileat the same time having a simple and economical structure.

[0015] Another advantage of several aspects of the present invention isthat it regards a device and method for teaching the proper techniquefor shaking a container prior to inhalation.

[0016] The present invention, together with further objects andadvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 schematically shows a top view of an aerosol dispensinginhaler training device according to the present invention;

[0018]FIG. 2 shows a perspective cut away view of an aerosol dispensingdevice to be used with the aerosol dispensing training devices of FIG.1;

[0019]FIG. 3 shows a cross-sectional view of the aerosol dispensingdevice of FIG. 2;

[0020]FIG. 4A shows a side cross-sectional view of the aerosoldispensing device of FIG. 2;

[0021]FIG. 4B shows an exploded perspective view of the aerosoldispensing device of FIG. 2;

[0022]FIG. 5 schematically shows a partial cross-sectional view of asecond embodiment of an aerosol dispensing training device according tothe present invention;

[0023]FIG. 6A shows a front view of a first embodiment of a flow ratemeasurement device at a resting position according to the presentinvention;

[0024]FIG. 6B shows a side view of the flow rate measurement device ofFIG. 6A at a resting position;

[0025]FIG. 6C shows a side view of the flow rate measurement device ofFIG. 6A when a gas is flowing;

[0026]FIG. 6D schematically shows a spirometer that employs the flowrate measurement device of FIGS. 6A-C;

[0027]FIG. 7A shows a side view of a second embodiment of a flow ratemeasurement device at a resting position according to the presentinvention;

[0028]FIG. 7B shows a side view of the flow rate measurement device ofFIG. 7A when a gas is flowing;

[0029]FIG. 8A shows a side view of a third embodiment of a flow ratemeasurement device at a resting position according to the presentinvention;

[0030]FIG. 8B shows a side view of the flow rate measurement device ofFIG. 8A when a gas is flowing in one direction;

[0031]FIG. 8C shows a side view of the flow rate measurement device ofFIG. 8A when a gas is flowing in a direction opposite to the flow ofFIG. 8B;

[0032]FIG. 8D schematically shows a life support ventilator that employsthe flow rate measurement device of FIGS. 8A-C;

[0033]FIG. 9A schematically shows a top view of a fourth embodiment of aflow rate measurement device to be used with the aerosol dispensingdevice of FIGS. 2-4;

[0034]FIG. 9B schematically shows a side view of the flow ratemeasurement device of FIG. 9A;

[0035]FIG. 10 shows a top view of an embodiment of a vane to be usedwith the flow rate measurement devices of FIGS. 2-4;

[0036]FIG. 11A shows an example of the flow rate or flowage measured bythe flow rate measurement devices of FIGS. 6-9;

[0037]FIG. 11B shows a flow chart for determining the flow rate usingthe flow rate measurement devices of FIGS. 6-9;

[0038]FIG. 12 shows a flow chart for determining proper shaking of thecontainer of FIGS. 2-5;

[0039]FIG. 13 schematically shows an embodiment of a processor to beused with the aerosol dispensing inhaler training device of FIGS. 1-5;

[0040]FIG. 14 schematically shows an embodiment of a display to be usedwith the aerosol dispensing inhaler training device of FIGS. 1-5;

[0041] FIGS. 16A-G schematically show several display screens shownduring the testing of a user; and

[0042] FIGS. 17A-E schematically show additional display screens shownduring the testing of a user.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

[0043] An aerosol dispensing inhaler training device 100 according tothe present invention is schematically shown in FIGS. 1-17, wherein likeelements are identified by like numerals. As described below, theaerosol dispensing inhaler training device 100 is basically made of 5major components: 1) the aerosol dispensing device 200, 2) the flow ratemeasurement device 300, 3) the shaking sensor 400, 4) the actuationsensor 500, and 5) the monitoring device 600. Each of these componentsis discussed below:

[0044] A. Aerosol Dispensing Device

[0045] FIGS. 1-5 show an aerosol dispensing device 200 that includes aT-shaped housing 202 and a cylindrical container 204 disposed therein.The housing 202 has a longitudinally extending cylindrical cavity 206shaped to receive the container. A top portion of the housing 202 isgenerally open such that the container 204 can be inserted into thehousing 202 through opening 208 and be installed therein with a bottomend 210 of the container 204 protruding from the housing 202 and exposedto the user for actuation.

[0046] The term “longitudinal” as used herein is intended to indicatethe direction of the reciprocal movement of the container 204 relativeto the housing 202. The terms “top,” “bottom,” “upwardly” and“downwardly” are intended to indicate directions when viewing theaerosol dispensing device 200 as shown in FIGS. 2-4, but with theunderstanding that the container 204 is inverted such that the topsurface thereof is located adjacent the bottom of the housing 202 andvice versa.

[0047] As shown schematically in FIGS. 2 and 4B, a cylindrical supportblock 212 having a movable well 214 is formed in a bottom portion 216 ofthe housing 202. The movable well 214 is cylindrical in shape and isinserted an orifice 218 that penetrates the support block 212 tocommunicate with a bottom portion of the movable well 214. A spring 219is also placed in the orifice 218 so that it surrounds the movable well214. The spring 219 acts to maintain the well 214 and the container 204away from an actuation position to be described below. A mouthpiece 216,intended for insertion into the mouth of a patient, forms an exhaustport 220 that has one end 222 in fluid communication with the movablewell 214 and a second end 224 in fluid communication with the ambientatmosphere 226. The exhaust port 220 has a length of approximately 3.5cm and an oval-like cross-section with a maximum width of approximatelyof 2.2 cm and a maximum height of approximately 1.5 cm. Of course, theexhaust port 220 may have other shapes, such as cylindrical orrectangular, without departing from the spirit of the invention. Themouthpiece 216 extends laterally from the housing 202 so as tofacilitate insertion of the mouthpiece into the mouth of the patient.

[0048] The cylindrical container 204 has a valve stem 228 extendinglongitudinally from the bottom end 230 of the container 204. The valvestem 228 extends coaxially from the container 204 and is biasedoutwardly therefrom by the spring 219 mounted within the container 204.The container 204 is mounted in the housing 202 by press fitting thevalve stem 228 in the well 214 of the support block 212.

[0049] In a preferred embodiment, the interior of the container 204 isfilled with a pressurized propellant and a placebo solution orsuspension which is dispensed therefrom in specific metered doses bydepressing or moving the valve stem 228 from an extended closed positionto a depressed open position. A single metered dose is dispensed fromthe container 204 by each reciprocal, longitudinal movement of the valvestem 228.

[0050] In operation, the opening of the valve stem 228 is effected bymoving the container 204 reciprocally within the housing 202 along alongitudinal axis, defined by the valve stem 228 and the reciprocalmovement of the container 204, by depressing the exposed bottom end 210of the container 204 relative to the housing 202 so as to move the valvestem 228 and the movable well 214 against the spring 219 to the open oractuation position as it is supported within the well by the supportblock 212. As the well 214 is moved to an actuation position where thevalve stem 228 is moved to the open position, the container 204dispenses a portion of the propellant and the placebo solution orsuspension within the container 204 through the well 214 and orifice218. A placebo aerosol is formed within the exhaust port 220. Thepatient inhales the placebo aerosol and the air within the exhaust port220 from the first end 222 of the exhaust port 220 to the second end 224of the exhaust port 220 so that the placebo aerosol is transmitted tothe patient through the mouthpiece 216. A grill 230 is formed in thebottom rear end 222 of the aerosol dispensing device 200 so as to allowambient air to be sucked through the grill and into a rectangularopening 232 that is formed in the aerosol dispensing device 200 so as tobe directly underneath the vane 302. The grill 230 has threelongitudinal slats that are parallel to one another and separated fromone another by approximately 0.2 cm so as to prevent particles largerthan 0.2 cm from entering the exhaust port 220. The rectangular opening232 has a length of approximately 0.9 cm and a width of approximately1.3 cm.

[0051] B. Flow Rate Measurement Device

[0052] One of the problems encountered by users of aerosol dispensingdevices in general is that the medication may not be inhaled properly.Accordingly, the aerosol dispensing inhaler training device 100 includesa flow rate measurement device 300 that is capable of measuring the flowrate of aerosol through the aerosol dispensing device 200. As shown inFIG. 2, the flow rate measurement device 300 preferably is attached tothe interior surface of the exhaust port 220 so as to be positionedbetween the well 214 and the rear end 222 of the aerosol dispensingdevice 200. Such a position is preferred because it reduces the amountof aerosol and placebo deposited on the flow rate measurement device 300and so the flow rate measurement device is able to measure theinhalation flow without impeding the flow of the aerosol which leads tomore accurate measurements of the flow rate within the exhaust port 220when a patient inhales through the mouthpiece 216.

[0053] An embodiment of such a flow rate measurement device 300 isschematically shown in FIGS. 6A-C. In particular, the flow ratemeasurement device 300 has two main components: a movable vane 302 and asensor 308. The base 309 of the movable vane 302 is secured by the topand bottom of the interior surface of the housing by being clampedtherebetween (see FIG. 2). Alternatively, the base 309 can be attachedto the bottom of the interior surface of the exhaust port 220 by a wellknown adhesive. As shown in FIG. 10, the vane 302 has a thickness ofapproximately 0.05 cm and a rectangular upper section 306 that has alength of approximately 1.9 cm and a width of approximately 1.35 cm. Thebase 309 has a length of approximately 0.5 cm and a width ofapproximately 1.2 cm and is integrally attached to a rectangular neck311 that has a length of approximately 0.65 cm and is integrallyattached to the upper section 306. The vane 302 is made of a spring-likematerial, such as stainless steel. Of course, other shapes for the vane302 and the upper section 306 are possible without departing from thespirit of the invention. When the patient is not inhaling through theexhaust port 220, the vane 302 stands vertically at a resting positionshown in FIG. 6B. When the patient inhales at the mouthpiece 216, thevane 302 pivots or bends so that the upper section 306 is deflectedtowards the mouthpiece 216 in the direction of the flow of the placeboaerosol and/or inhaled air as shown in FIG. 6C. Note that the vane 302preferably bends only when the patient inhales and not when the placeboaerosol is dispensed. However, there may be instances where the vane 302is positioned within the flow path and/or has its spring constantadjusted so that it is deflected when the aerosol placebo is alsodispensed. In that case, the vane 302 should occlude approximately 50%of the area impinged by the flow where the vane 302 is located.

[0054] Two examples of where the vane 302 is positioned within the flowpath is shown in FIGS. 5 and 6D. FIG. 6D shows the vane 302 being usedas a flow sensor for a basic pulmonary function spirometer 313.Spirometry is the measurement of lung function and is highly dependenton patient effort. To measure the various lung capacities for volume andflow, the patient exhales at end 315 which causes the exhaled air todeflect the vane 302 and then the exhaled air leaves through the exitend 317 to the atmosphere. From the deflection of the vane 302, amicroprocessor can calculate and display such parameters as the peakflow and the FEV1 value. The test results may be compared againstaccepted norms for individuals with similar height, weight, age and sex.Of course, the spirometer 313 may incorporate automated analysis ofresults, allow entry of patient data, transmit results electronically,etc.

[0055] The application of the vane 302 would be used for direct flowmeasurement and integrate this information for presentation of volumedata. Prior art using other flow sensing methods are more expensive ordelicate than this invention. The invention is robust and unaffected bycontamination with aerosols from the patient's exhaled gas, by exposureto liquids or cleaning solutions.

[0056] The amount of movement or deflection of the upper section 306 ofthe vane 302 is a measure of the flow rate or flowage within the exhaustport 220. A magnetic sensor 308, such as a Hall element or amagnetoresistive element, is used to measure the movement or deflectionof the upper section 306 of the vane 302 from the rest position of FIG.6B to the deflected position of FIG. 6C. In particular, the sensor 308measures the deflected position by detecting the magnetic field strengthgenerated by a magnetic element, such as a high energy permanent magnet310 or an electromagnet, at that position and generating a signalcorresponding to the amount of movement of the movable vane 302. Themagnetic element 310 is attached to the upper section 306 and preferablyis a permanent magnet, such as a type II Neodymium-Iron-Boron (NeFeB)magnet. The magnetic field produced by the permanent magnet preferablyis unaffected by moisture, liquids and external magnetic fields and isrelatively stable over temperature and time. One way to protect themagnetic element 310 from the environment is to place a thin plastic,such as polyester, over the magnetic element 310.

[0057] As shown in the embodiment of FIGS. 6A-D, the sensor 308 isattached to the top of a support 312 that is itself attached to theinterior surface of the exhaust port 220. The sensor 308 is positionedabove the interior surface of the exhaust port 220 and is adjacent tomagnetic element 310 at the rest position shown in FIG. 6B. Like thevane 302, a protective layer of thin plastic can be placed over thesensor 308 to protect it from the environment.

[0058] A second embodiment of a flow rate measurement device 300 isshown in FIGS. 7A-B where the flow rate measurement device 300 of FIGS.6A-C is altered by adding a second magnetic element 314 that is spacedfrom the sensor 308 by approximately 2 mm at the rest position shown inFIG. 7A. The magnetic element 314 is attached to the vane 302 via an arm316.

[0059] As shown in FIGS. 8A-8D, a third embodiment of a flow ratemeasurement device 300 is a variation of the flow rate measurementdevice 300 of FIGS. 7A-B where the vane 302 is offset from the support312 by approximately 1 mm at the rest position. This results in themagnetic element 310 being spaced from the sensor 308 at the restposition by approximately 1 mm. As shown in FIGS. 8B and 8C, offsettingthe vane 302 allows the flow rate measurement device 300 to measure theflow rate in two directions and to determine which direction the flow ismoving within the exhaust port 220. This provides the advantage ofsensing the flow rate when the user exhales into the exhaust port 220.

[0060] An example of the use of a bi-directional sensor is shown in FIG.8D where the vane 302 is used as a flow sensor in a section of a lifesupport ventilator circuit 319. The ventilator circuit is the commondescriptor for the tubing, connectors and other components that confineand direct gas from a ventilator to the patient, and potentially backagain. It is well known that a ventilator, or other life support orbreathing assist device, acts to provide air or air with additionaloxygen, plus humidity, at breathing rates and volumes sufficient tomaintain or support life or provide assistance in breathing. As shown inFIG. 8D, the vane 302 (approximate length 3 inches, approximate mass 20grams) is positioned to measure flow to and from the patient. Thesignals from the deflection of the vane 302 may be used to integrate theflow data to produce a gas volume that can be displayed on a monitor orsent to other locations. Once patient is through with the ventilator,the vane 302 can be either entirely disposable or partially disposableso that a cleaner vane 302 can be used for the next use.

[0061] A fourth embodiment of a flow rate measurement device 300 isshown in FIGS. 9A-B. In this preferred embodiment, the vane 302 isoriented horizontally rather than vertically as in FIGS. 6-8 so that thefree end 318 points toward the mouth piece 216 and along the flow of thegas. In this embodiment, the magnetic element 310 is attached to the topsurface of the vane 302 so as to be approximately 0.375 cm from the freeend 318 and approximately 0.675 cm from either of the side edges 320 ofthe vane 302. The sensor 308 is attached to bottom platform 322 so as toface the bottom of the vane 302. When there is no flow, the bottomsurface of the vane 302 may be either adjacent to the sensor 308 or maybe preloaded so that it is spaced approximately 0.6 cm from the sensor308.

[0062] Note that several variations of the flow rate measurement devices300 of FIGS. 6-9 are possible. For example, the sensor 308 could beattached to the vane 302 and the magnetic element 310 could be mountedon the support 312 or mounted on or in the interior wall of the exhaustport 220. Another variation is to preload or stress the vane 302 so thata minimum gas flow is required to cause deflection of the vane 302.

[0063] The spring-like characteristics of the vanes 302 of FIGS. 6-9 canbe altered to meet specific requirements for specific applications. Forexample, the aerosol dispensing device can be enlarged for largeranimals, like horses, or reduced in size for children. For each newapplication, the spring-like characteristics of the vane 302 can beoptimized for deflection distance, physical size, resistance to airflow(back pressure) and vane material selection. In the case of being usedfor large animals, the vane 302 would be large and thick while the vane302 for children would be small and thin.

[0064] An example of the flow rate or flowage measured by the flow ratemeasurement devices of FIGS. 6-9 is shown in FIG. 11a. It is believedthat the specific curve in FIG. 11A will shift up or down during thelife of the measurement devices, but the shape (gain) of the curve willremain the same. In each of the embodiments of FIGS. 6-9, the flow rateor flowage in the exhaust port 220 is determined by applying the stepsshown in the flow chart of FIG. 11b that are carried out by themicroprocessor 602, such as a 4-bit microcontroller. It is predictedthat the ratio of the voltage signal, Vmax, generated by the sensor 308at maximum flowage where the vane 302 is at maximum deflection to thevoltage signal Vmin where the vane 302 is at the rest position is aconstant K at all times. The constant K is preferably measured at thetime of manufacture or calibration of the flow rate measurement device300 and is stored in a memory of the microprocessor 602. Duringoperation of the flow rate measurement device 300, the voltage signalVrest generated by the vane 302 being at the rest position when thedevice 300 is first turned on is fed to and stored in the microprocessor602. The microprocessor 602 calculates and stores the predicted voltageVmaxdef for maximum deflection of the vane 302 by determining the valueof the multiplicative product of K times the stored value of Vrest.Next, the full range of voltages that can be measured from no deflectionto maximum deflection is determined by subtracting the voltage Vrest forthe rest position from the calculated voltage Vmaxdef for maximumdeflection. This subtraction also reduces the effect on the voltage ofsuch factors as manufacturing tolerances and temperature. The full rangeof voltages is then divided into seven sub-ranges, where each sub-rangecorresponds to one of the seven bar graphs on the flow rate display 604of the monitoring device 600. The sub-ranges are determined by firstincrementing the voltage Vrest in sixteen steps that equal six percentof the full range of voltages. The flow rate for each increment is thencompared with five subranges of flow rates where the subrange of flowrate that corresponds to the increment is displayed on display 606 asshown in FIGS. 14-15. An example of the sub-ranges of the flow ratedisplay 604 is given FIGS. 11B and 15 and in the table below: Sensor %of Full Range Nearby Flow Voltage Voltage step × 6% 0 1.55 0 0 5 1.5560.9 0 10 1.732 26.4 4 15 1.864 45.6 8 20 1.966 60.4 10 25 2.046 72.0 1230 2.112 81.6 14 35 2.165 89.3 15 40 2.205 95.1 16 45 2.239 100 16

[0065] The full range of voltages and the sub-ranges are preferablyrecalculated with each use. It is understood that the resolution of thesub-ranges can be increased or decreased by altering the size of theincremental steps so that a desired resolution can be achieved. Onepossible set of sub-ranges is: less than 15 l/min, 15-25 l/min, 25-35l/min, 35-40 l/min, 40-45 l/min, 45-50 l/min and greater than 50 l/minwhere the upper and lower ranges are unacceptable flow rates.

[0066] C. Shake Sensor

[0067] Besides measuring the flow rate, the moving vane 302 can beadapted to be a shake sensor 400. This is accomplished by adding a mass402 to either of the vanes 302 shown in FIGS. 6-9. As shown in FIG. 9A,the mass 402 is attached to the upper section 306 by an adhesive so thatit is centered at approximately 0.9 cm from the free end 318 of the vane302 and 0.675 cm from either of the side edges 320. The mass 402 has anannular shape with a thickness of approximately 0.2 cm, an inner radiusof approximately 0.15 cm and an outer radius of approximately 0.4 cm.The mass 402 preferably is made of stainless steel and has a mass ofapproximately 0.41 grams. The mass 402 performs the function ofincreasing the amount of force needed to affect acceleration therebycausing greater deflection of the vane 302 which can be more easilymeasured.

[0068] With the mass 402 attached to the vane 302, the voltage signalgenerated by the magnetic sensor 308 is processed by the microprocessor602 so as to measure differential changes in the position of the vane302 when the housing 202 is shaken or agitated. Measuring thedifferential changes allows the microprocessor to measure theacceleration of the housing 202. As shown in the flow chart of FIG. 12,the measured differential changes are compared with a predetermineddifferential change value that is stored in the microprocessor 602. Atypical value of the stored predetermined differential change valuewould be 2.5 times the acceleration of gravity (g=9.8 m/s/s). The storedpredetermined differential change value is representative of anacceptable acceleration caused by one shake of the container 204. Duringthe comparison stage, the microprocessor 602 determines whether themeasured differential change is above or below the predetermineddifferential change value. If it is above, a counter is incremented byone to register that a single adequate shake has been performed. Inaddition, a beep is generated signaling that the shake was adequate andindicating that another shake should be performed. The second shake isperformed and the comparison with the predetermined differential changevalue is repeated. If the shake is acceptable, then the counter isincremented another step and a second beep is generated indicating thesecond shake was acceptable and that a third shake should be performed.The above process is continued until eight consecutive adequate shakesare performed where the microprocessor 602 signals, via display 604,that the container 204 is properly shaken and the next step of inhalingis to be attempted by the user. If an inadequate shake is performed atany time before reaching eight consecutive adequate shakes, then thecounter is reset to zero and the user must start over and attempt to doeight consecutive adequate shakes in the manner described above.

[0069] Note that during each shake the value of the counter is comparedwith a stored number, such as eight, representative of the minimumnumber of shakes to properly mix the contents of the container 204 forconsumption by a user.

[0070] As can be seen above, the signal generated by the vane 302 can beused by the microprocessor to measure a number of quantities, such asthe position of the vane, the acceleration of the vane, the position ofthe vane in time, etc., and so can be used to generate other usefulquantities, such as peak flow rate, to monitor the use of the device200.

[0071] A second embodiment of a shake sensor is shown in FIG. 5. Inparticular, a shake sensor 400 is attached to the exterior side of thehousing 202. The shake sensor 400 is in the shape of a cylindrical tube404 having a radius of approximately 6 mm and a height of approximately10 mm. The top end of the shake sensor 400 is capped off and the bottomend of the shake sensor 400 has a flexible contact surface 406 attachedthereto so as to enclose the cylindrical tube 404. The contact surface406 is circular in shape and is preferably made of plated copper.

[0072] Inside of the cylindrical tube 404 is ambient air. A contactmember, such as the spherical ball 408, is placed in the tube 404 aswell. The ball 408 is preferably made of steel, has a radius ofapproximately 3 mm, and has a mass of approximately 100 grams.

[0073] The shake sensor 400 operates as follows: The housing 202 and thecontainer 204 are agitated or shaken. Since the tube 404 is attached tothe housing 202, the tube 404 and the ball 408 are also shaken and movedin response to the shaking of the housing 202 and the container 204. Ameasure of the amount of agitation is the number of times that the ball408 contacts the contact surface 406. Each contact between the ball 408and the contact surface 406 is detected by a transducer or sensor 410that is attached to the exterior side of the contact surface 406.

[0074] The signal generated by the sensor 410 is sent to themicroprocessor 602 where it is processed in the same manner as thesignal generated by the sensor 308 of FIGS. 2-4 and 6-9. To summarize,the signal is compared with a predetermined value indicative of anacceptable shake or agitation. The number of acceptable shakes oragitations is counted and compared with the previously described storednumber representative of the minimum number of shakes or agitations toproperly agitate and mix the contents of the container 204 forconsumption by a user. If the number of measured shakes or agitations isbelow the stored number, then a signal or beep is generated by themicroprocessor 602 that another shake or agitation is required. Thisprocess is continued until the stored number is reached where themicroprocessor 602 signals that the container 204 is properly shaken oragitated and the next step of inhaling is to be attempted by the user.If an inadequate shake is performed at any time before reaching eightconsecutive adequate shakes or agitations, the user must start over andattempt to do eight consecutive adequate shakes or agitations in themanner described above.

[0075] D. Actuation Sensor

[0076] As previously described, the flow rate measurement devices 300and the shake sensors 400 are used to measure whether the magnitude ofthe flow rate within the exhaust port 220 and the agitation of thecontainer 204 are adequate for using an aerosol dispensing device.Another important function of the aerosol dispensing inhaler trainingdevice 100 is to test the timing of the dispensing process, such as theshaking of the container 204 and the inhalation of the aerosol. To thisend, an initiation or activation sensor 500 is used to detect when aportion of the propellant and the placebo within the container 204 isdispensed into the exhaust port 220 for inhalation.

[0077] The actuation sensor 500 is attached to the bottom of the housing202 so as to be located within the housing 202 and directly below eitherthe well 214 (FIGS. 2-4) or the top surface of the container 204 (FIG.5) The actuation sensor 500 is a conventional contact sensor, such as amembrane switch. The sensor 500 can be protected from the environment byplacing a thin plastic, such as polyester, over the sensor 500.

[0078] When the container 204 is not moved, the top surface of thecontainer 204 is spaced above the sensor 500 and the bottom of thehousing 202. When the bottom end of the container 204 is depressed itmoves the valve system 228 to the open position that results in thedispensing of a portion of the placebo into the exhaust port 220. Whenthe valve is first opened, the top surface of the container 204 (FIG. 5)or the bottom of the movable well 214 (FIGS. 2-4) first makes contactwith the sensor 500. This results in the generation of a signal that isrepresentative of the time when the housing 202 or the movable well 214is moved to an actuation position where the valve stem is first openedand actuated so that the placebo is dispensed in an aerosol form. Thissignal is sent to the microprocessor 602 which then determines whetheror not the timing of the operation of the aerosol dispensing device isproper. An explanation of the processing of the signal is discussed inthe section below.

[0079] E. Monitoring Device and Training Procedure

[0080] As described above, the three signals from the flow ratemeasurement devices 300 of FIGS. 6-9, the shake sensors 400 of FIGS. 2-5and the actuation sensor 500 are sent to the microprocessor 602 residingin the monitoring device 600 as shown in FIG. 12 (in the case of theshake sensor and the flow rate measurement devices being incorporated inthe same vane 302, the shake sensor box can be eliminated). Themonitoring device 600 monitors itself and processes the signals so thata user of the aerosol dispensing device 200 can learn how to properlyuse the device 200 and dispensing devices like it. In particular, oncethe monitoring device 600 is switched on, it runs a testing program thatgoes step-by-step through the process of using the device 200 whileusing the signals from the sensors to determine if a step has beensuccessfully completed. The program monitors the completion or failureof a step to determine whether the testing should proceed or should berepeated. The program also informs the microprocessor which sensors ormeasurements are being measured.

[0081] The monitoring device 600 is preferably powered by two AAalkaline batteries so as to be portable. Of course it is possible to useother power sources without departing from the spirit of the invention.Once the monitoring device 600 is turned on by pushing the ON-OFF switch604, the liquid crystal display (LCD) 606 is lit up so as to showseveral pictures as shown in FIGS. 1 and 14. Upon being turned on, themicroprocessor 602 monitors the batteries and displays the remainingpower in the batteries via the display of a battery A. As the batteriesbecome weaker, the interior 608 of the displayed battery A will becomelower and lower so as to indicate that new batteries will be needed.Besides monitoring the batteries, the microprocessor 602 checks if theother sensors are working properly. If so, a check mark B is displayed(see screen of FIG. 16A), and if not, the check mark B and a slash C aredisplayed simultaneously (see screen of FIG. 16B).

[0082] Assuming that the monitoring device 600 is in proper runningorder and check mark B is displayed, the display 606 will flash thearrow D near the picture of the dispensing device E (see FIG. 16C). Theflashing arrow D alerts the user to attempt to adequately shake thecontainer 204 eight consecutive times. A beep will be emitted by aspeaker 608 after every successful shake. No beep will be generated ifthe shake is unsuccessful. The lack of a beep also indicates that theuser must start from the beginning and attempt to achieve the eightconsecutive adequate shakes.

[0083] When eight consecutive adequate shakes are achieved, the display606 changes. First, it shows a clear screen with a check mark B (FIG.17E) indicating the stage has been successfully completed and then itchanges to a screen showing a trachea F connected to a pair of lungs G(see FIG. 16D). Flashing dots are shown in the trachea F. A vertical bargraph H and up and down arrows I and J are also displayed. This signalsthe user to place his or her mouth over the mouthpiece 216 and practiceinhaling. By inhaling, the vane 302 will be moved. As describedpreviously, the signal generated by the sensor 308 is representative ofthe flow rate. The microprocessor 602 compares the measured inhalationflow rate with two stored values representing the high end and low endof acceptable inhalation flow rates. If the measured flow rate is belowthe stored low end value, then the up arrow I will flash and a highfrequency of beeps will be generated to alert the user to increase theflow rate. If the measured flow rate is above the stored high end value,then the down arrow J flashes and a low frequency of beeps is heard towarn the user to decrease the flow rate.

[0084] Once an acceptable inhalation flow rate is achieved, a beep willoccur and a new screen showing a check mark B (FIG. 17E) will be shownon the display 606. Next, a new screen is shown that alerts the userthat the inhalation of the placebo aerosol will be tested next As shownin FIG. 16E, a flashing finger K is displayed near the dispensing deviceE. The flashing finger K is a cue for the user to depress the container204 while maintaining the inhalation performed during the steprepresented by the screen of FIG. 16D. Upon depression of the container204, the placebo is dispensed into the exhaust port 220. The container204 (FIG. 5) or the bottom of the movable well 214 (FIGS. 2-4) contactsthe actuation sensor 500 which results in a signal being sent to themicroprocessor 602 and the call up of the screen of FIG. 16F onto thedisplay 606. If the user does not continue inhaling when activating thecontainer 204, then the screen of FIG. 17D will show up on the display606. Note that the screen of FIG. 16F will also be called up if thecontainer 204 is not pressed within two seconds of the call up of thescreen of FIG. 16E. Note that the screen of FIG. 16F will include an “X”that signifies a failed attempt.

[0085] When the screen 16F is called up, the patient should still beperforming the inhalation begun with the screen of FIG. 16D. Themicroprocessor 602 monitors the flow rate signals from the vane 302 andmeasures the flow rate from those signals. If the measured flow rate ismaintained for two seconds within the range represented by the middlefive green bars of the bar graph H (see FIG. 15), then a check mark isdisplayed (FIG. 17E). Next, another new screen (see FIG. 16G) isdisplayed where the lungs G and trachea F flash for five seconds toremind the user to hold his or her breath for the same five seconds. Ifthe measured flow rate is not maintained for the first second then theuser is given an additional second to achieve an acceptable flow rate.If an unacceptable flow rate is not achieved during the two secondperiod, then a failure signal is shown and heard and the user is sentback to the shake step. If an acceptable flow rate is achieve in thesecond one second interval, a signal is displayed and a beep soundsindicating the attempt was unsuccessful and that the user should repeatthe attempt of inhaling properly for two seconds.

[0086] The monitoring device 600 has several other features. Forexample, if the batteries need replacing, then the screen of FIG. 17A isshown on the display 606.

[0087] It is possible to review a user's test results at differentstages of the testing process. This is done by pressing the memorybutton 608. Pressing the button 608 once results in a display of thenumber of tests attempted and the percentage that were successful. Twopresses causes a display like FIG. 16D with the percentage of times thatthe inhaling at that stage was successful. Three presses results in adisplay like FIG. 17C where the percentage displayed is the percentageof times the container 204 was successfully actuated. A fourth presscauses a display like FIG. 17D where the percentage displayed is thepercentage of tests that the user inhaled the placebo aerosol at theproper flow rate for two seconds. A fifth press returns the screen tothat of FIG. 16C.

[0088] Although the present invention has been described with referenceto preferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. For example, the present invention can beused to diagnose or monitor a patient's pulmonary condition. Inaddition, the present invention is equally applicable to triggering theactivation of various aerosol delivery devices, such as metered doseinhalers or nebulizers and can be used to train patients to inhale otherproducts properly, such as dry powders. It is understood that dependingon the type or delivery device or product inhaled, that themicroprocessor 602 will need to be reprogrammed to test for parametersthat will indicate proper usage of the device and/or proper inhalationof the product. It is contemplated, though, that the testing andmonitoring for the new device or inhalation product will be similar tothat described above. With the above comments in mind, it is intendedthat the foregoing detailed description be regarded as illustrativerather than limiting and that it is the appended claims, including allequivalents thereof, which are intended to define the scope of theinvention.

We claim:
 1. An aerosol dispenser comprising: a container comprising aninterior; a shake sensor positioned within an interior of said aerosoldispenser, said shake sensor determining whether the contents of saidinterior of said container have been properly agitated for consumptionby a user.
 2. The aerosol dispenser comprising: a movable vane attachedwithin said interior of said aerosol dispenser.
 3. The aerosol dispenserof claim 2, comprising a sensor to measure the amount of acceleration ofsaid movable vane.
 4. The aerosol dispenser of claim 2, comprising amass attached to said movable vane.
 5. The aerosol dispenser of claim 3,comprising a mass attached to said movable vane.
 6. The aerosoldispenser of claim 3, wherein said movable vane comprises a magneticelement that is sensed by said sensor.
 7. The aerosol dispenser of claim6, wherein said magnetic element is adjacent to said sensor at a restposition.
 8. The aerosol dispenser of claim 6, wherein said magneticelement is spaced from said sensor at a rest position.
 9. The aerosoldispenser of claim 6, said movable vane comprising a second magneticelement that is sensed by said sensor.
 10. The aerosol dispenser ofclaim 9, wherein said second magnetic element is adjacent to said sensorat a rest position.
 11. The aerosol dispenser of claim 10, wherein saidsecond magnetic element is spaced from said sensor at said restposition.
 12. The aerosol dispenser of claim 9, wherein said magneticelement is spaced from said sensor at a rest position.
 13. The aerosoldispenser of claim 12, wherein said second magnetic element is spacedfrom said sensor at said rest position.
 14. The aerosol dispenser ofclaim 1, wherein said shake sensor comprises a contact member and acontact surface, wherein said contact member moves in response tomovement of said container.
 15. The aerosol dispenser of claim 14,wherein said shake sensor detects the number of times said contactmember contacts said contact surface.
 16. The aerosol dispenser of claim14, wherein said shake sensor comprises a cylindrical tube wherein saidcontact surface is attached to an end of said cylindrical tube.
 17. Theaerosol dispenser of claim 16, wherein said contact surface is circularand encloses said end of said cyl indrical tube.
 18. The aerosoldispenser of claim 16, wherein said contact member comprises a sphericalball positioned within said cylindrical tube.
 19. The aerosol dispenserof claim 17, wherein said contact member comprises a spherical ballpositioned within said cylindrical tube.
 20. The aerosol dispenser ofclaim 1, wherein said shake sensor comprises a transducer attached tosaid contact surface.
 21. The aerosol dispenser of claim 16, whereinsaid shake sensor comprises a transducer attached to said contactsurface.
 22. A method of determining whether the contents of a containerhave been properly mixed for consumption by a user, said methodcomprising the steps of: agitating the contents contained within acontainer; determining the number of times said contents within saidcontainer are agitated; and comparing the number of times said contentswithin said container are agitated with a predetermined numberrepresentative of an adequate number of times said contents within saidcontainer should be agitated for consumption by a user.
 23. The methodof claim 22, comprising the step of: generating a signal when saidnumber of times said contents within said container are agitated isequal to said predetermined number that indicates that said contentswithin said container are properly mixed for consumption by a user. 24.The method of claim 22, wherein said determining step comprises countingthe number of times a movable vane is accelerated beyond a predeterminedacceleration value, wherein said movable vane is accelerated in responseto said agitating step.
 25. The method of claim 22, wherein saiddetermining step comprises counting the number of times a contact memberattached to said container contacts said contact member, wherein saidcontact member moves in response to said agitating step.
 26. An aerosoldispenser for dispensing a liquid in aerosol form comprising: acontainer having a valve stem extending longitudinally therefrom andmovable between a closed position and an open position, said containerdispensing a portion of the contents within said container when saidvalve stem is moved to the open position; a housing adapted to supportsaid container reciprocally moveable within said housing along alongitudinal axis, said housing comprising a well adapted to receivesaid valve stem and an exhaust port comprising one end in fluidcommunication with said well and a second end in fluid communicationwith the ambient atmosphere, wherein said portion of said aerosol isdispensed from said first end of said exhaust port to said second end ofsaid exhaust port such that said portion of said contents within saidcontainer is dispensed through said second end of said exhaust port whensaid valve stem is moved to the open position; and a flow measurementdevice comprising a movable vane attached to said housing between saidfirst end and said second end of said exhaust port, wherein said movablevane has a shape that occludes 50% or less of the area of defined bysaid second opening.
 27. The aerosol dispenser of claim 26, comprising asensor to measure the amount of movement of said movable vane.
 28. Theaerosol dispenser of claim 26, wherein said movable vane pivots from arest position where said movable vane is positioned when none of thecontents within said container is flowing through said exhaust port to asecond position that is representative of the flowage of said contentswithin said container when said portion of said contents within saidcontainer flow through said exhaust port.
 29. The aerosol dispenser ofclaim 28, comprising a sensor to measure said second position.
 30. Theaerosol dispenser of claim 27, wherein said movable vane comprises amagnetic element that is sensed by said sensor.
 31. The aerosoldispenser of claim 29, wherein said movable vane comprises a magneticelement that is sensed by said sensor.
 32. The aerosol dispenser ofclaim 31, wherein said magnetic element is adjacent to said sensor at said rest position.
 33. The aerosol dispenser of claim 31, wherein saidmagnetic element is spaced from said sensor at said rest position. 34.The aerosol dispenser of claim 30, said movable vane comprising a secondmagnetic element that is sensed by said sensor.
 35. The aerosoldispenser of claim 34, wherein said second magnetic element is adjacentto said sensor at said rest position.
 36. The aerosol dispenser of claim35, wherein said second magnetic element is spaced from said sensor atsaid rest position.
 37. The aerosol dispenser of claim 34, wherein saidmagnetic element is spaced from said sensor at said rest position. 38.The aerosol dispenser of claim 37, wherein said second magnetic elementis spaced from said sensor at said rest position.
 39. An aerosoldispensing inhaler training device for determining whether a user isproperly operating an aerosol dispensing device, said aerosol dispensinginhaler training device comprising: an aerosol dispensing devicecomprising: a container having a valve stem extending longitudinallytherefrom and movable between a closed position and an open position,said container dispensing a portion of the contents within saidcontainer when said valve stem is moved to the open position; and ahousing adapted to support said container reciprocally moveable withinsaid housing along a longitudinal axis from a first position, saidhousing comprising a well adapted to receive said valve stem and anexhaust port comprising one end in fluid communication with said welland a second end in fluid communication with the ambient atmosphere,wherein said portion of said contents within said container is dispensedfrom said first end of said exhaust port to said second end of saidexhaust port when said housing moves to an actuation position where saidvalve stem is actuated so that said portion of said contents within saidcontainer is dispensed through said second end of said exhaust port whensaid valve stem is moved to the open position; a flow measurement devicecomprising a movable vane with a magnetic element, said movable vane isattached to said housing and is located within said housing, a flowsensor that generates a first signal corresponding to the amount ofmovement of said movable vane; and an initiation sensor that generates asecond signal that indicates when said housing is moved to saidactuation position and said valve stem is actuated.
 40. The aerosoldispensing inhaler training device of claim 39, comprising a memory thatstores an optimum flow rate value for a person inhaling said portion ofsaid aerosol; a microprocessor that receives said first signal andcalculates the flow rate of said portion of said contents within saidcontainer through said vane; and a comparator that compares said optimumflow rate value with said calculated flow rate and generates either anacceptance signal if the calculated flow rate is greater or equal tosaid optimum flow rate value or a failure signal if the calculated flowrate is less than said optimum flow rate value.
 41. The aerosoldispensing inhaler training device of claim 40, comprising a visualdisplay for displaying said calculated flow rate.
 42. The aerosoldispensing inhaler training device of claim 40, comprising a speaker forgenerating a sound that indicates whether or not said calculated flowrate is acceptable.
 43. The aerosol dispensing inhaler training deviceof claim 39, wherein said movable vane has a shape that occludes 50% orless of the area defined by said second end.
 44. The aerosol dispensinginhaler training device of claim 39, wherein said movable vane pivotsfrom a rest position where said movable vane is positioned when none ofthe contents within said container is flowing through said exhaust portto a second position that is representative of the flowage of saidportion of said contents within said container flows through saidexhaust port.
 45. An aerosol dispensing inhaler training device fordetermining whether a user is properly operating an aerosol dispensingdevice, said aerosol dispensing inhaler training device comprising: anaerosol dispensing device comprising: a container having a valve stemextending longitudinally therefrom and movable between a closed positionand an open position, said container dispensing a portion of saidcontents within said container when said valve stem is moved to the openposition; and a housing adapted to support said container reciprocallymoveable within said housing along a longitudinal axis from a firstposition, said housing comprising a well adapted to receive said valvestem and an exhaust port comprising one end in fluid communication withsaid well and a second end in fluid communication with the ambientatmosphere, wherein said portion of said contents within said containeris dispensed from said first end of said exhaust port to said second endof said exhaust port when said housing moves to an actuation positionwhere said valve stem is actuated so that a portion of said contentswithin said container is dispensed through said second end of saidexhaust port when said valve stem is moved to the open position; a flowmeasurement device comprising a movable vane attached to said housingand located within said housing, a flow sensor that generates a firstsignal corresponding to the amount of movement of said movable vane; anda shake sensor positioned within said interior of said container, saidshake sensor determining whether said contents within said containerhave been properly agitated for consumption by a user.
 46. The aerosoldispensing inhaler training device of claim 45, comprising a sensor tomeasure the amount of acceleration of said movable vane.
 47. The aerosoldispensing inhaler training device of claim 46, wherein said movablevane comprises a magnetic element that is sensed by said sensor.
 48. Theaerosol dispensing inhaler training device of claim 46, comprising amass attached to said movable vane.
 49. The aerosol dispensing inhalertraining device of claim 47, comprising a mass attached to said movablevane.
 50. The aerosol dispensing inhaler training device of claim 45,wherein said shake sensor comprises a contact member and a contactsurface, wherein said contact member moves in response to movement ofsaid container.
 51. The aerosol dispensing inhaler training device ofclaim 50, wherein said shake sensor detects the number of time s saidcontact member contacts said contact surface.
 52. The aerosol dispensinginhaler training device of claim 45, comprising a memory that stores anoptimum flow rate value for a person inhaling said portion of saidcontents within said container; a microprocessor that receives saidfirst signal and calculates the flow rate of said portion of saidcontents within said container through said vane; and a comparator thatcompares said optimum flow rate value with said calculated flow rate andgenerates either an acceptance signal if the calculated flow rate isgreater or equal to said optimum flow rate value or a failure signal ifthe calculated flow rate is less than said optimum flow rate value. 53.The aerosol dispensing inhaler training device of claim 52, comprising avisual display for displaying said calculated flow rate.
 54. The aerosoldispensing inhaler training device of claim 52, comprising a speaker forgenerating a sound that indicates whether or not said calculated flowrate is acceptable.
 55. The aerosol dispensing inhaler training deviceof claim 45, wherein said movable vane has a shape that occludes 50% orless of the area of defined by said second end.
 56. The aerosoldispensing inhaler training device of claim 45, wherein said movablevane pivots from a rest position where said movable vane is positionedwhen none of the contents within said container is flowing through saidexhaust port to a second position that is representative of the flowageof said portion of said contents within said container flows throughsaid exhaust port.
 57. The aerosol dispensing inhaler training device ofclaim 45, comprising a memory that stores a predetermined numberrepresentative of an adequate number of times said contents within saidcontainer should be agitated for proper mixing for consumption by auser; a microprocessor that receives signals from said mixing sensor andcalculates the number of times that said contents within said containerare agitated; and a comparator that compares said predetermined numberwith said calculated number of times that said contents within saidcontainer are agitated and generates an acceptance signal if thecalculated number of times that said contents within said container areagitated is equal to said predetermined number.
 58. An aerosoldispensing inhaler training device for determining whether a user isproperly operating an aerosol dispensing device, said aerosol dispensinginhaler training device comprising: an aerosol dispensing devicecomprising: a container having a valve stem extending longitudinallytherefrom and movable between a closed position and an open position,said container dispensing a portion of the contents within saidcontainer when said valve stem is moved to the open position; and ahousing adapted to support said container reciprocally moveable withinsaid housing along a longitudinal axis from a first position, saidhousing comprising a well adapted to receive said valve stem and anexhaust port comprising one end in fluid communication with said welland a second end in fluid communication with the ambient atmosphere,wherein said portion of said contents within said container is dispensedfrom said first end of said exhaust port to said second end of saidexhaust port when said housing moves to an actuation position where saidvalve stem is actuated so that a portion of said contents within saidcontainer is dispensed through said second end of said exhaust port whensaid valve stem is moved to the open position; an actuation sensor thatgenerates a second signal that indicates when said housing is moved tosaid actuation position and said valve stem is actuated; and a shakesensor that determines whether said contents within said container havebeen properly agitated for consumption by a user.
 59. The aerosoldispensing inhaler training device of claim 58 comprising: a movablevane attached to said housing.
 60. The aerosol dispensing inhalertraining device of claim 59, comprising a sensor to measure the amountof acceleration of said movable vane.
 61. The aerosol dispensing inhalertraining device of claim 60, wherein said movable vane comprises amagnetic element that is sensed by said sensor.
 62. The aerosoldispensing inhaler training device of claim 60, comprising a massattached to said movable vane.
 63. The aerosol dispensing inhalertraining device of claim 61, comprising a mass attached to said movablevane.
 64. The aerosol dispensing inhaler training device of claim 58,wherein said shake sensor comprises a contact member and a contactsurface, wherein said contact member moves in response to movement ofsaid container.
 65. The aerosol dispensing inhaler training device ofclaim 64, wherein said shake sensor detects the number of times saidcontact member contacts said contact surface.
 66. The aerosol dispensinginhaler training device of claim 58, comprising a memory that stores apredetermined number representative of an adequate number of times saidcontents within said container should be agitated for proper consumptionby a user; a microprocessor that receives signals from said mixingsensor and calculates the number of times that said contents with saidcontainer are agitated; and a comparator that compares saidpredetermined number with said calculated number of times that saidcontents within said container are agitated and generates an acceptancesignal if the calculated number of times that said contents within saidcontainer are agitated is equal to said predetermined number.
 67. Anaerosol dispensing inhaler training device for determining whether auser is properly operating an aerosol dispensing device, said aerosoldispensing inhaler training device comprising: an aerosol dispensingdevice comprising: a container having a valve stem extendinglongitudinally therefrom and movable between a closed position and anopen position, said container dispensing a portion of the contentswithin said container when said valve stem is moved to the openposition; and a housing adapted to support said container reciprocallymoveable within said housing along a longitudinal axis from a firstposition, said housing comprising a well adapted to receive said valvestem and an exhaust port comprising one end in fluid communication withsaid well and a second end in fluid communication with the ambientatmosphere, wherein said portion of said contents within said containeris dispensed from said first end of said exhaust port to said second endof said exhaust port when said housing moves to an actuation positionwhere said valve stem is actuated so that said portion of said contentswithin said container is dispensed through said second end of saidexhaust port when said valve stem is moved to the open position; a flowmeasurement device comprising a movable vane attached to said housingbetween said first end and said second end of said exhaust port, a flowsensor that generates a first signal corresponding to the amount ofmovement of said movable vane; an actuation sensor that generates asecond signal that indicates when said housing is moved to saidactuation position and said valve stem is actuated; and a shake sensorpositioned within said interior of said container, said shake sensordetermining whether said contents within said container have beenproperly agitated for consumption by a user.
 68. The aerosol dispensinginhaler training device of claim 67 comprising: a movable vane attachedto said housing.
 69. The aerosol dispensing inhaler training device ofclaim 68, comprising a sensor to measure the amount of acceleration ofsaid movable vane.
 70. The aerosol dispensing inhaler training device ofclaim 69, wherein said movable vane comprises a magnetic element that issensed by said sensor.
 71. The aerosol dispensing inhaler trainingdevice of claim 69, comprising a mass attached to said movable vane. 72.The aerosol dispensing inhaler training device of claim 70, comprising amass attached to said movable vane.
 73. The aerosol dispensing inhalertraining device of claim 67, wherein said shake sensor comprises acontact member and a contact surface, wherein said contact member movesin response to movement of said container.
 74. The aerosol dispensinginhaler training device of claim 73, wherein said shake sensor detectsthe number of times said contact member contacts said contact surface.75. The aerosol dispensing inhaler training device of claim 67,comprising a memory that stores an optimum flow rate value for a personinhaling said portion of said contents within said container; amicroprocessor that receives said first signal and calculates the flowrate of said portion of said portion of said contents within saidcontainer through said vane; and a comparator that compares said optimumflow rate value with said calculated flow rate and generates anacceptance signal if the calculated flow rate is equal to said optimumflow rate value.
 76. The aerosol dispensing inhaler training device ofclaim 75, comprising a visual display for displaying said calculatedflow rate.
 77. The aerosol dispensing inhaler training device of claim75, comprising a speaker for generating a sound that indicates whetheror not said calculated flow rate is acceptable.
 78. The aerosoldispensing inhaler training device of claim 75, wherein said movablevane has a shape that occludes 50% or less of the area of defined bysaid second end.
 79. The aerosol dispensing inhaler training device ofclaim 75, wherein said movable vane pivots from a rest position wheresaid movable vane is positioned when none of the contents within saidcontainer is flowing through said exhaust port to a second position thatis representative of the flowage of said portion of said contents withinsaid container flows through said exhaust port.
 80. The aerosoldispensing inhaler training device of claim 75, comprising a memory thatstores a predetermined number representative of an adequate number oftimes said contents within said container should be agitated forconsumption by a user; a microprocessor that receives signals from saidmixing sensor and calculates the number of times that said contentswithin said container are agitated; and a comparator that compares saidpredetermined number with said calculated number of times that saidcontents within said container are agitated and generates either anacceptance signal if the calculated number of times that said contentswithin said container are agitated is greater or equal to saidpredetermined number or a failure signal if the calculated number oftimes that said contents within said container are agitated is less thansaid predetermined number.
 81. A method of training an individual on howto properly use an aerosol dispensing device by an individual, saidmethod comprising the steps of: a) agitating a container; b) determiningwhether the contents within said container have been properly agitatedduring said agitating step a) for consumption by an individual; and c)repeating steps a) and b) if it is determined during step b) that saidcontents within said container have not been properly agitated duringsaid step a) for consumption by an individual.
 82. The method of claim81, wherein said determining step b) comprises determining the number oftimes said contents within said container is agitated; and comparing thenumber of times said contents within said container are agitated with apredetermined number representative of an adequate number of times saidcontents within said container should be agitated for consumption by auser.
 83. A method of training an individual on how to properly use anaerosol dispensing device by an individual, said method comprising thesteps of: a) agitating a container; b) dispensing the contents withinsaid container; c) determining whether said contents within saidcontainer have been properly agitated during said agitating step a) forconsumption by an individual; and d) determining whether said contentswithin said container have been properly dispensed from said container.84. The method of claim 83, wherein said determining step c) comprisesdetermining the number of times said contents within said container areagitated; and comparing the number of times said contents within saidcontainer are agitated with a predetermined number representative of anadequate number of times said contents within said container should bemixed for proper mixing for consumption by a user.
 85. The method ofclaim 84, wherein said determining step c) comprises determining theflow rate of said contents within said container dispensed duringdispensing step b) and comparing the flow rate with an optimum flow ratefor a person inhaling said dispensed contents within said container. 86.The method of claim 83, wherein said determining step c) comprisesdetermining when said contents within said container are dispensed instep b).
 87. The method of claim 85, wherein said determining step c)further comprises determining when said contents within said containerare dispensed in step b).